BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE PATELLA RESURFACING SIZE 2

    MDR report key: 9170627 · Received October 9, 2019

    Report

    Report Number
    3005180920-2019-00847
    Event Type
    Injury
    Date Received
    October 9, 2019
    Date of Event
    September 9, 2019
    Report Date
    October 9, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030815751
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON (B)(6) 2019. LOT 180394: (B)(4) ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2018. EXPIRATION DATE: 2023-04-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN, 13 MONTHS AFTER PRIMARY SURGERY, COMPLAINING OF PAIN DUE TO A DISLOCATION OF THE PATELLA. THE SURGEON PLANS TO REVISE THE FEMUR AND TIBIA. THE REVISION SURGERY HAS BEEN SCHEDULED FOR (B)(6) 2019. MORE DETAILS TO FOLLOW ONCE THE REVISION SURGERY IS COMPLETE. THE REVISION SURGERY WAS NOT PERFORMED. THERE IS NO RESCHEDULED REVISION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    964355 GMK-SPHERE PATELLA RESURFACING SIZE 2 RESURFACING PATELLA JWH MEDACTA INTERNATIONAL SA 180394 07630030815751

    Patients

    Seq Age Sex Outcome Treatment
    1 Other